ABSTRACT
Purpose
A generic product must meet the standards established by the Food and Drug Administration (FDA) to be approved for marketing in the USA. FDA approves a generic product for marketing if it is proved to be therapeutically equivalent to the reference product. Bioequivalence (BE) between a proposed generic product and its corresponding reference product is one of the major components of therapeutic equivalence. These approvals may be delayed if the BE portion of the submission is determined to be deficient. Many of these BE deficiencies recur commonly and can be avoided.
Method
We conducted a survey of the BE submissions to abbreviated new drug applications (ANDAs) over years 2001 to 2008 to identify the most commonly occurring BE deficiencies.
Results
Recurring deficiencies are found in a majority of the ANDAs reviewed by FDA’s Division of Bioequivalence. The most common deficiencies were the two deficiencies related to dissolution (method and specifications) found in 23.3% of the applications and analytical method validation and/or report found in 16.5% of the applications. The approval of generic drugs would be greatly accelerated if these deficiencies could be avoided.
This is a preview of subscription content, log in via an institution to check access.
REFERENCES
Generic Pharmaceutical Association. http://www.gphaonline.org/media/press-releases/2009/02/12/gpha-congratulates-president-elect-barack-obama-and-new-congress-and (assessed 2011, May 2)
Approved products with therapeutic equivalence evaluations. 31st edition. Washington, DC: US Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs, 2009. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf (assessed 2011, May 2)
U.S. Food and Drug Administration Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf
U.S. Food and Drug Administration Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070241.pdf
Model Bioequivalence Data Summary Tables. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM120957.pdf
U.S. Food and Drug Administration External Dissolution Methods Database: http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm
U.S. Food and Drug Administration Guidance for Industry: Bioequivalence Recommendations for Specific Products: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm
Author information
Authors and Affiliations
Corresponding author
Additional information
Disclaimer
This article reflects the views of the author and should not be construed to represent FDA’s views or policies.
Rights and permissions
About this article
Cite this article
Liu, Q., Davit, B.M., Cherstniakova, S.A. et al. Common Deficiencies with Bioequivalence Submissions in Abbreviated New Drug Applications Assessed by FDA. AAPS J 14, 19–22 (2012). https://doi.org/10.1208/s12248-011-9312-7
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1208/s12248-011-9312-7